Acute Intervention to Reduce Distress Following Sexual Assault

• Sponsor: Medical University of South Carolina (Other)
• Overall Status: Completed
• CT.gov ID: NCT01622855
• Collaborator: National Institute on Drug Abuse (NIDA) (NIH)
• Enrollment: 442
• Location: 1
• Arms: 2
• Duration (Months): 102
• Patients Per Site Per Month: 4.3

Study Details

Study Description

Brief Summary

The purpose of this study was to evaluate whether a brief intervention in video format delivered in the post assault medical exam setting and including education about assault reactions and instruction in and modeling of successful coping strategies would reduce post assault drug use or abuse and PTSD symptoms as compared to standard care.

Condition or Disease	Intervention/Treatment	Phase
Drug Use; Drug Abuse; Posttraumatic Stress Disorder	Behavioral: PPRS	Phase 1/Phase 2

Detailed Description

The intervention being evaluated was shown at the time of the post assault medical exam and includes two main components: preparation for the medical exam; and information about and modelling of coping strategies that may help women cope in the aftermath of assault. The intervention content is delivered via video. Intervention and standard care groups were compared with regard to measures of substance use and abuse and symptoms of PTSD and other potentially comorbid problems including symptoms of depression or other anxiety.

Study Design

• Study Type: Interventional
• Actual Enrollment: 442 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Outcomes Assessor)
• Primary Purpose: Prevention
• Official Title: Prevention of Post-Rape Psychopathology and Drug Abuse
• Study Start Date: Mar 1, 1997
• Actual Primary Completion Date: Sep 1, 2005
• Actual Study Completion Date: Sep 1, 2005

Arms and Interventions

Arm	Intervention/Treatment
Experimental: PPRS video Prevention of post sexual assault stress	Behavioral: PPRS; Video including psycho-education and modeling of adaptive behavioral coping strategies for use post-assault.
No Intervention: Standard care Receipt of standard services

Outcome Measures

Primary Outcome Measures

1. Frequency of specific drug use [14 days]

   Number of days use of specific drugs in preceding 14 days at 6 week, 3 and 6 month follow-ups

Secondary Outcome Measures

1. Specific Drug Abuse [1.5, 3, 6 months]

   Criteria for DSM-IV substance abuse based on structured interview

2. PSS-SR [2 weeks]

   Measure of PTSD symptoms

Eligibility Criteria

Criteria

• Ages Eligible for Study: 14 Years to 90 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Seeking medical care after recent sexual assault

Exclusion Criteria:

• Active psychosis

• Active suicidality

• Cognitive impairment

• Non-English speaking

• Severe injury

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Medical University of South Carolina	Charleston	South Carolina	United States	29412

Sponsors and Collaborators

• Medical University of South Carolina
• National Institute on Drug Abuse (NIDA)

Investigators

• Principal Investigator: Heidi Resnick, Ph.D., Medical University of South Carolina

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Medical University of South Carolina
• ClinicalTrials.gov Identifier: NCT01622855
• Other Study ID Numbers: NCT11158; R01DA011158
• First Posted: Jun 19, 2012
• Last Update Posted: Apr 22, 2015
• Last Verified: Apr 1, 2015

• Keywords provided by Medical University of South Carolina: Rape; Secondary prevention; Intervention
• Additional relevant MeSH terms: Substance-Related Disorders; Stress Disorders, Post-Traumatic

Study Results

No Results Posted as of Apr 22, 2015